This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

The purpose of this article is to report what can be learned about nurses’ ethical conflicts by the systematic analysis of methodologically similar studies. Five studies were identified and analysed for: (1) the character of ethical conflicts experienced; (2) similarities and differences in how the conflicts were experienced and how they were resolved; and (3) ethical conflict themes underlying four specialty areas of nursing practice (diabetes education, paediatric nurse practitioner, rehabilitation and nephrology). The predominant character of the ethical conflicts was (...) disagreement with the quality of medical care given to patients. A significant number of ethical conflicts were experienced as ‘moral distress’, the resolution of which was variable, depending on the specialty area of practice. Ethical conflict themes underlying the specialty areas included: differences in the definition of adequacy of care among professionals, the institution and society; differences in the philosophical orientations of nurses, physicians and other health professionals involved in patient care; a lack of respect for the knowledge and expertise of nurses in specialty practice; and difficulty in carrying out the nurse’s advocacy role for patients. (shrink)

Policy‐makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right‐to‐try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right‐to‐try movement asserts? What is government’s proper role in regulating and facilitating access to drugs that are still in (...) development? In this review, we analyze the history of the right‐to‐try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement’s consequences. Two possible scenarios may emerge. One is that the right‐to‐try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right‐to‐try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations. (shrink)

Whistleblowers remain essential as complainants in allegations of research misconduct. Frequently internal to the research team, they are poorly protected from acts of retribution, which may deter the reporting of misconduct. In order to perform their important role, whistleblowers must be treated fairly. Draft regulations for whistleblower protection were published for public comment almost a decade ago but never issued. In the face of the growing challenge of research fraud, we suggest vigorous steps, to include: organizational responsibility to certify the (...) accuracy of research including audit, required whistleblower action in the face of imminent or grave harm to subjects, strengthened legal protections against retaliation including prompt enactment of Federal whistleblower protections and consideration of criminalizing the most egregious cases of research misconduct. (shrink)

Research misconduct remains an important problem in health research despite decades of local, national, regional, and international efforts to eliminate it. The ultimate goal of every health research project, irrespective of setting, is to produce trustworthy findings to address local as well as global health issues. To be able to lead or participate meaningfully in international research collaborations, individual and institutional capacities for research integrity are paramount. Accordingly, this paper concerns itself not only with individuals’ research skills but also with (...) institutional and national policies and governance. Such policies and governance provide an ethical scaffold for the production of knowledge and structure incentives. This paper’s operational definition of research therefore draws from Institute of Medicine’s articulation of health research as an inquiry that aims to produce knowledge about the structure, processes, or effects of personal health services; and from an existing health systems framework. The paper reviews the research regulatory environment and the ethics apparatus in Ghana, and describes a project jointly undertaken by Ghanaian researchers in collaboration with New York University to assess the perceived adequacy of current institutional practices, opportunities, and incentives for promoting RI. (shrink)

An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about (...) ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest. (shrink)

An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about (...) ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest. (shrink)

ABSTRACT Patient self‐management (SM) of chronic disease is an evolving movement, with some forms documented as yielding important outcomes. Potential benefits from proper preparation and maintenance of patient SM skills include quality care tailored to the patient's preferences and life goals, and increase in skills in problem solving, confidence and success, generalizable to other parts of the patient's life. Four central ethical issues can be identified: 1) insufficient patient/family access to preparation that will optimize their competence to SM without harm (...) to themselves, 2) lack of acknowledgement that an ethos of patient empowerment can mask transfer of responsibility beyond patient/family competency to handle that responsibility, 3) prevailing assumptions that preparation for SM cannot result in harm and that its main purpose is to deliver physician instructions, and 4) lack of standards for patient selection, which has the potential to exclude individuals who could benefit from learning to SM. Technology assessment offers one framework through which to examine available data about efficacy of patient SM and to answer the central question of what conditions must be put in place to optimize the benefits of SM while assuring that potential harms are controlled. (shrink)

Ethics rounds in clinical ethics have already taken hold in multiple venues. There are “sit-down rounds,” which usually consist of a bioethicist setting a specific, prescheduled time aside for residents and/or others to bring a case or two for discussion with the bioethicist. Another kind of rounds that occurs on an ad hoc or infrequent basis is to have either a staff or outside bioethicist give hospital-wide and/or departmental “grand rounds.” Grand rounds is a traditional educational format in medicine and (...) adding bioethics to the topics covered in grand rounds is an important means of elevating ethical awareness within a department or throughout a healthcare organization. Newer is the rounding practice of adding a bioethicist to other established rounding processes, such as case management and utilization review rounds. All of these kinds of ethics rounds are important opportunities to elevate the level of moral discourse within a healthcare setting and are becoming part and parcel of any full-service hospital bioethics program. (shrink)

An analysis of current biomedical research misconduct policy that proposes a new approach emphasizing the context of misconduct and improved oversight. Federal regulations that govern research misconduct in biomedicine have not been able to prevent an ongoing series of high-profile cases of fabricating, falsifying, or plagiarizing scientific research. In this book, Barbara Redman looks critically at current research misconduct policy and proposes a new approach that emphasizes institutional context and improved oversight. Current policy attempts to control risk at the individual (...) level. But Redman argues that a fair and effective policy must reflect the context in which the behavior in question is embedded. As journalists who covered many research misconduct cases observed, the roots of fraud “lie in the barrel, not in the bad apples that occasionally roll into view.” Drawing on literature in related fields—including moral psychology, the policy sciences, the organizational sciences, and law—as well as analyses of misconduct cases, Redman considers research misconduct from various perspectives. She also examines in detail a series of clinical research cases in which repeated misconduct went undetected and finds laxity of oversight, little attention to harm done, and inadequate correction of the scientific record. Study questions enhance the book's value for graduate and professional courses in research ethics. Redman argues that the goals of any research misconduct policy should be to protect scientific capital (knowledge, scientists, institutions, norms of science), support fair competition, contain harms to end users and to the public trust, and enable science to meet its societal obligations. (shrink)

The proportion of research misconduct cases among trainees in the biomedical sciences has risen, raising the question of why, and what are the responsibilities of research administrators and the research community to address this problem. Although there is no definitive research about causes, for trainees the relationship with a research mentor should play a major role in preventing actions that constitute research misconduct. Examination of the limited literature and of the number of cases closed by the US Office of Research (...) Integrity between 2009 and 2013 raises questions about the mentor-student relationship and what it should be accomplishing. But many gaps in policy and its implementation inhibit this role. There is no acknowledgement of mentorship in federal regulations and research on how to teach research integrity is woefully underdeveloped, especially for international trainees. And some institutional research integrity officers may have had little preparation for the role. (shrink)

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision (...) and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. (shrink)

While nearly all patients with a chronic disease must self-manage their condition to some extent, preparation for these responsibilities is infrequently assured in the USA. The result can be significant harm and the undermining of a patient’s ability to take advantage of life opportunities and be productive. Agreeing to care for a patient involves a moral responsibility to see that she or he receives the essential elements of care, including the ability to manage the disease on a daily basis. The (...) research base for the efficacy of self-management and for how patients can be prepared to assume it is sufficiently strong that health care professionals must advocate for its inclusion in the routine evidence-based care of individuals with chronic disease. Because patient education is central to nursing’s philosophy and practice, the profession should play a major role in removing structural barriers to self-management preparation and assuring its provision to a high standard of quality. (shrink)

Healthcare rationing during pandemics has been widely discussed in global bioethics literature. However, existing scenarios and analyses have focused on high income countries, except for very few disease areas such as HIV treatment where some analyses related to African countries exist. We argue that the lack of scholastic discourse, and by extension, professional and democratic engagement on the subject constitute an unacceptable ethical omission. Not only have African governments failed to develop robust ethical plans for pandemics, ethicists in this region (...) have been unable to ignite public discourse on rationing. Therefore, we aim to initiate a debate on how rationing health and social goods could be done ethically in Ghana during the current and future pandemics. The paper discusses and critiques some moral considerations for rationing and their relevance in the Ghanaian context. This contribution may facilitate ethical decision-making during the current pandemic - in Ghana and other African settings where hardly any rationing guidelines exist. (shrink)

20 years ago, the Report of the Commission on Research Integrity was submitted to the Secretary of the Department of Health and Human Services and to House and Senate Committees. As directed in enabling legislation, the Commission had provided recommendations on a new definition of research misconduct, oversight of scientific practices, and development of a regulation to protect whistleblowers. Reflecting the ethos of the time, the Commission recommended that institutions receiving Public Health Service research funding should provide oversight of all (...) but the most egregious misconduct. The suggested definition of research misconduct was organized around misappropriation, interference and misrepresentation, which would have addressed collaborative/authorship disputes and sabotage in scientific laboratories, both of which remain unaddressed in current policy. The Commission also recommended the Whistleblower Bill of Rights and Responsibilities which would have authorized remedies for whistleblowers who experienced retaliation and sanctions against retaliators. Response from the scientific community was highly critical, and none of the Commission’s recommendations was accepted. No new body has examined issues within the Commission’s charge, there has been no significant Congressional or public pressure to do so, institutions have not been able to sustain standards that would have avoided current concerns about bias and irreproducibility in research, and there is still no entity in science capable of addressing issues assigned to the Commission and other urgent issues. (shrink)

A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here we describe four areas of research misconduct regulations governing Public Health Service funded research that are empirically and/or ethically questionable. Policies for human subject protection, RM and conflict of interest are not harmonized, making it extremely difficult to deal with complex cases which often contain allegations in all of these areas. Second, detection of RM has (...) depended entirely on whistleblowers in spite of evidence of significant under-reporting. Third, the scientific record is far from cleansed of the effects of falsified/fabricated work through current mechanisms of retraction. Finally, lack of fairness in the regulations may reflect lack of a Belmont Report-like document to guide ethics of RM policy. These issues are likely common in other countries. RM regulations should be harmonized with related regulations and their effectiveness tracked, open access to data for independent replication and improved statistical tests are an essential supplement to whistleblowers, correction of the scientific record will require a major effort, and further ethical analysis and guidance are as important as is empirical study for the improvement of RM regulations. Further consideration should be given to assigning current regulations for human subjects protection, RM and conflict of interest to a single authority and to the further development of a Belmont-like report of essential principles, for RM. (shrink)

Data alteration requires consideration of: what are data, when should they be available and what is their quality. Alteration may be intended or unintended: scientific misconduct, scientific error, use of questionable research practices, or community-based and cultural interpretations of data relevance. Situations in which data alteration are at risk include those in which conflict of interest (and thus potential for bias) is endemic, and those in which powerful incentives that do not support research integrity are present. Consequences of intentional and (...) unintentional data alteration are morally important but are not uniformly addressed. Norm and governance changes from the current system are in initial stages of development and must address issues of the data revolution. Points of decision address ethical concerns and moral quandaries researchers will likely face in a system of research practice that does not comprehensively support research integrity. (shrink)

Although patient education is central to the ethical practice of nursing, it can be practiced in an ethically contested or unethical way. It is sometimes used to: forward a societal goal the individual might not have chosen; assume that patients should learn to accommodate unjust treatment; exclude the views of all except the dominant health care provider group; limit the knowledge a patient can receive; make invalid or unreliable judgments about what a patient can learn; or require a patient to (...) change his or her identity to meet a medical ideal. Both health promotion education and manipulating patient beliefs in situations of uncertainty are ethically contested. Nussbaum's capabilities approach is used here as a moral framework through which to view the goals and practice of patient education. This provides better guidance than the current conception of patient education as an instrument to carry out the directives of medical practice. (shrink)

There is an urgent need in biomedical science to understand whether regulations are being met, prerequisite to goals of subject protection and integrity in research practice. This article presents an update of a 2006 summary of measurement instruments in research ethics with psychometric information in the years 2008−2012. A review of 25 instruments identified seven used in the time period 2008−2012 and which had accumulated at least one study of its psychometric qualities beyond its developmental phase. Many of these instruments (...) had been accumulating psychometric information over more than a decade. Two additional but still underdeveloped instruments addressing important bioethical issues − coercion and therapeutic misconception − are included because they address important issues in research ethics. Bioethicists use a wide range of methods for knowledge development and verification; each method should meet stringent standards of quality. Measurement instruments that meet these standards have the potential to greatly ease the work of institutional review boards and other regulatory bodies as well as to enhance empirical work on human research ethics. (shrink)